Improving Latent Tuberculosis (TB) Diagnosis in Thai Children (TB Px)

This study has been completed.

Sponsor:

South East Asia Research Collaboration with Hawaii

ClinicalTrials.gov Identifier:

NCT00947609

First Posted: July 28, 2009

Last Update Posted: June 6, 2012

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The study is a prospective study to improve the diagnosis and management of latent TB in HIV-infected and HIV uninfected children in Thailand. The objectives are to assess the sensitivity and specificity of IGRAs (T-Spot®.TB, a T-cell-based assay, and QuantiFERON®-TB Gold In-tube, a whole blood assay), TST, and a refined symptom-based questionnaire in diagnosing latent TB in 166 HIV-infected and HIV uninfected children in Thailand, and to evaluate the influence of age, nutritional and immune status on children's response to the IGRAs. These children will be screened for TB with a detailed TB contact history, symptom-based questionnaire, physical examination, TST, chest radiograph (and abdominal ultrasound for those with abdominal symptoms), IGRAs, and clinical specimens for acid fast bacilli stain and culture. A diagnostic algorithm will be generated using the combination of test modalities with the highest sensitivity and specificity results.

HIV-infected and HIV uninfected children with recent exposure to adults with active tuberculosis will be referred to the two study sites (HIV-NAT/Chulalongkorn and Queen Sirikit) for eligibility screening and enrollment in the study.

Detailed Description:

Study Objectives

To compare the utility of IGRAs, T-Spot®.TB and QuantiFERON®-TB Gold In-Tube, and TST for screening of latent TB in HIV-infected children

To compare these different screening modalities in HIV-infected children to HIV uninfected children

To assess the influence of age, nutritional and immune status, prior BCG and TST status on children's response to IGRAs

To assess the prognostic value of IGRAs vs. TST in predicting development of active TB in children over 9 months

Research questions:

Primary:

What is the sensitivity and specificity of IGRAs and TST in screening for latent TB in HIV-infected and HIV uninfected children in Thailand?

Secondary:

How do age, nutritional and immune status, prior BCG and PPD status influence children's response to IGRAs? What is the prognostic value of IGRAs vs. TST in predicting development of active TB in children over 9 months?

This is a prospective cohort study conducted at two sites in Bangkok, Thailand: HIV Netherlands Australia Thailand (HIV-NAT) Clinic/Chulalongkorn Hospital and Queen Sirikit National Institute of Child Health.

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:

2 Months to 16 Years (Child)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Sampling Method:

Non-Probability Sample

Study Population

Thai children between the ages of 2 months and 16 years with exposure to active TB adult cases will be referred to the two study sites for eligibility screening.

Criteria

Inclusion Criteria:

Have close contact with a person > 15 years of age who had active pulmonary (± extrapulmonary), sputum AFB positive TB (household member or non-household member with contact > 120 hours/month) during the past year

Are between the ages of 2 months and 16 years

Parents or caregivers provide informed consent to participate

Provide child assent for children aged ≥ 7 years

Exclusion Criteria:

Child and/or parent/caregiver who refuse study participation

Are currently receiving antituberculosis medications for TB disease

Have recently been diagnosed with active TB within past 6 months

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00947609

Locations

Thailand

HIV Netherlands Australia Thailand (HIV-NAT) Research Organization

Bangkok, Thailand

Queen Sirikit National Institute of Child Health

Bangkok, Thailand

Sponsors and Collaborators

South East Asia Research Collaboration with Hawaii

Columbia University

New York Blood Center

HIV Netherlands Australia Thailand Research Collaboration

Queen Sirikit National Institute of Child Health

Investigators

Principal Investigator:

Jintanat Ananworanich, MD, PhD

South East Asia Research Collaboration with Hawaii, HIV Netherlands Australia Thailand Research Collaboration, Bangkok, Thailand